Patient Information Leaflet

PARACODOL® CAPSULES

Paracetamol (500mg) Codeine Phosphate Hemihydrate (8mg)

Please read this leaflet carefully because it contains important information for you.

Keep this leaflet, you may need to read it again.

•    This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

•    You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.

•    This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

•    If you take this medicine for headaches for more than three days it can make them worse.

1.    What are Paracodol Capsules for?

Paracodol Capsules are a combination of pain killers: codeine and paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. This medicine can only be used in patients aged 12 years and over for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This includes muscular and rheumatic pains, headache, migraine, neuralgia, period pain, toothache, aches and pains.

2.    Before you take Paracodol Capsules

! This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

! If you take a painkiller for headaches for more than three days it can make them worse.

Do not take:

•    For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome

•    If you are taking anything else containing paracetamol.

•    If you are allergic to any of the ingredients.

•    If you know that you metabolise codeine very rapidly into morphine

•    If you are breast-feeding

Consult your doctor before taking Paracodol Capsules if you:

•    Are taking prescription medicines.

•    Are taking medicines containing codeine, metoclopramide, domperidone, colestyramine, warfarin or other coumarin anticoagulants.

•    Are taking medicines which affect the liver.

•    Have a liver or kidney condition.

Codeine is transformed into morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents (12-18 years old)

Do not use in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

The product is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Pregnancy and breast-feeding

Consult your doctor before taking the capsules if you are pregnant or think you may be pregnant.

Do not take codeine while you are breast-feeding. Codeine and morphine passes into breast milk.

Driving and using machines

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

-    Do not drive while taking this medicine until you know how it affects you.

-    It may be an offence to drive when taking this medicine.

-    However, you would not be committing an offence if:

•    The medicine has been taken to treat a medical or dental problem and

•    You have taken it according to the information provided with the medicine and

•    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Details regarding a new UK driving offence, concerning driving after drugs have been taken, may be found at: www.gov.uk/drug-driving-law.

3. How should I take Paracodol Capsules?

This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

Adults aged 18 years and over: Take 1-2 capsules, repeated if necessary every 4-6 hours with a maximum of 8 capsules a day.

Children aged 12 -18 years: Take 1 capsule, repeated if necessary every 4-6 hours with a maximum of 4 capsules a day.

Paracodol Capsules should not be taken by children under 12 years due to the risk of severe breathing problems.

Do not drink alcohol whilst taking this medicine.

Withdrawal - when you stop taking Paracodol Capsules:

This medicine contains codeine and can cause addiction if you take it continuously for more than three days.

When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

What if I take too many Paracodol Capsules?

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

4.    Do Paracodol Capsules cause any side effects?

Some people may have side-effects when taking this medicine.

Potential side-effects

Side effects are rare, but occasionally Paracodol Capsules can cause constipation and hypersensitivity reactions such as skin rashes. Very rare cases of serious skin reactions have been reported. If you notice that you bruise or bleed more easily than usual or if you are more prone to infection, such as sore throats or mouth ulcers, you should speak to your doctor.

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side-effects you can help provide more information on the safety of this medicine.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

5.    How should I store Paracodol Capsules?

Do not store above 25°C, i.e. this medicine may be stored at room temperature. Keep out of the sight and of reach children. Do not use the capsules after the expiry date on the carton and blister.

6.    Further Information

What do Paracodol Capsules contain?

Paracodol Capsules contain the active ingredients: paracetamol 500 mg and codeine phosphate 8 mg.

Inactive ingredients: pregelatinised maize starch, colloidal silicon dioxide, magnesium stearate (E572), titanium dioxide, gelatin, shellac (E904), red iron oxide (E172) and propylene glycol.

Available in packs of 10, 20 and 32 capsules. Not all pack sizes may be marketed.

Who makes Paracodol Capsules?

Manufactured by Wrafton Laboratories Ltd, Wrafton, Braunton, North Devon EX33 2DL for the Product Licence holder, Bayer plc, Consumer Care Division, Newbury, Berkshire, RG14 1JA, UK.

Leaflet last revised: October 2016. PARACODOL® is a registered trademark. Bayer